FDA committees to discuss vedolizumab, metreleptin

FDA's Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees will meet on Dec. 9 to discuss two BLAs for vedolizumab from the Millennium Pharmaceuticals Inc. subsidiary of Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). One application is under Priority Review for moderately to severely active ulcerative colitis (UC), while the other is under standard review for Crohn's disease. Takeda is seeking approval for both indications for patients who have had an inadequate response to, have lost response to or were intolerant to either conventional therapy or anti- tumor necrosis factor (TNF) alpha therapy. The pharma had originally submitted a single BLA to FDA but said the agency chose to review the indications under different timelines. Takeda expects a decision for the UC indication by Feb. 18, 2014. Vedolizumab is a humanized mAb against integrin alpha(4)beta(7). ...